Functional and Respiratory Rehabilitation and Nutritional Care of COVID-19 Patients (RECOVER-19)

COVID Clinical Trial

— RECOVER-19  

Official title:

Functional and Respiratory Rehabilitation and Nutritional Care of COVID-19 Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04466800
• Other study ID #: 35RC20_9875_RECOVER-19
• Status: Completed
• Phase: N/A
• Start date: July 30, 2020
• Est. completion date: January 13, 2023

Study information

• Verified date: January 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Following the acute phase of COVID, some patients may have sequelae, such as breathing difficulties or malnutrition. We hypothesize that a functional and respiratory rehabilitation program associated with personalized nutritional care will improve quality of life, physical performance and respiratory capacities and will decrease the prevalence of malnutrition among those patients.

Description:

In France, more than 150 000 patients have been infected by the SARS-CoV-2 virus and COVID has been responsible for more than 100 000 hospitalizations. Following the acute phase of this disease, some patients may have sequelae, such as breathing difficulties or malnutrition. However, the prevalence and intensity of those sequelae still remain unknown. Thus, a functional and respiratory rehabilitation program associated with personalized nutritional care may be necessary to improve those patients' prognosis.

This study aims to evaluate the effectiveness of a 4-week rehabilitation program following the acute phase of COVID. This program includes regular physical activity supervised by a physical acticity educator, a systematic malnutrition screening and a nutritional follow-up performed by a dietitian. Patients will be randomized in two groups: rehabilitation program (intervention group) or usual care (control group). Quality of life, physical performance, respiratory capacities and nutritional status will be assessed in both groups at inclusion and one month later (corresponding to the end of the rehabilitation program for the intervention group).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 13, 2023
• Est. primary completion date: August 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age above 18 years

• Laboratory (RT-PCR and/or serology) confirmed infection with SARS-CoV-2

• Date of first symptoms of SARS-CoV-2 infection > 4 weeks and < 4 months

• Persisting functional and/or respiratory deficit and/or asthenia and/or malnutrition beyond the first 4 weeks after COVID, defined as :

• Increase of mMRC (Modified Medical Research Council) score = 1 between the month before COVID and beyond the first 4 weeks after COVID and/or

• Asthenia score (Pichot asthenia scale) > 22 beyond the first 4 weeks after COVID, if patient had no asthenia before COVID (asthenia score <8) and/or

• Weight loss > 5% within 6 months, comparing minimum weight between the month before COVID and beyond the first 4 weeks after COVID and/or

• BMI (Body Mass Index) < 20 (if age < 70 years) or < 22 (if age = 70 years) if BMI (Body Mass Index) = 20 (if age < 70 years) or = 22 (if age = 70 years) the month before COVID

• Patient affiliated to social security system

• Patient gave written informed consent

Exclusion Criteria:

• Patient unable to undergo a rehabilitation program due to comorbidities, such as major cardio-vascular disease or severe dementia

• Patient currently benefiting from physiotherapy sessions, in particular motor and / or respiratory therapy and / or an exercise re-training and / or respiratory rehabilitation program

• Patient living in a residential facility for dependent elderly people

• Patient not speaking french

• Pregnant women

Related Conditions & MeSH terms

• COVID

Intervention

Other:
• Intervention group_rehabilitation program
Regular physical activity, supervised by a physical education educator, a systematic malnutrition screening and a nutritional follow-up performed by a dietetician. Patients will follow a 4-week rehabilitation program, comprising 3 physical activity sessions per week for 4 weeks. First sessions will be supervised by a physical activity educator and patients will perform the following sessions at home, using physical training software. The physical activity educator will call patients once a week to ensure the sessions are correctly performed and adapt the program if necessary. Patients will also undergo a nutritional assessment carried out by a dietitian at the beginning of the program. A dietitian will call patients once a week to ensure their nutritional status is appropriate.

Locations

Country	Name	City	State
France	Hôtel Dieu Paris	Paris
France	Centre Hospitalier de Cornouaille	Quimper
France	CHU Rennes	Rennes
France	Centre Hospitalier de Saint-Brieuc	Saint-Brieuc
France	Centre Hospitalier Bretagne Atlantique	Vannes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of a multidisciplinary and personalized rehabilitation program on COVID patients's quality of life	Physical component score of the Short-Form 36 health survey between the beginning and the end of the rehabilitation program (from 0 to 100; highers scores mean better outcome)	1 month
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Physical capacities	Number of repeated chair rises during 3 minutes	1 month
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Physical capacities	Aerobic physical capacity using Eval-DM software	1 month
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities	Modified Medical Research Council scale (mMRC) (from 0 to 4, highers scores mean worse outcome)	1 month
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities	Modified Medical Research Council scale (mMRC) (from 0 to 4, highers scores mean worse outcome)	3 months
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities	Modified Medical Research Council scale (mMRC) (from 0 to 4, highers scores mean worse outcome)	6 months
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities	Borg scale (from 0 to 10, highers scores mean worse outcome)	1 month
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Functional capacities	Barthel scale (from 0 to 100, highers scores mean worse outcome)	1 month
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Functional capacities	Barthel scale (from 0 to 100, highers scores mean worse outcome)	3 months
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Functional capacities	Barthel scale (from 0 to 100, highers scores mean worse outcome)	6 months
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria	Weight loss	1 month
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria	Weight loss	3 months
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria	Weight loss	6 months
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria	Body mass index	1 month
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria	Body mass index	3 months
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria	Body mass index	6 months
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria	Muscular mass by brachial circumference or grip strength	1 month
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria	SEFI® score (from 0 to 10, highers scores mean better outcome)	1 month
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria	SEFI® score (from 0 to 10, highers scores mean better outcome)	3 months
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria	SEFI® score (from 0 to 10, highers scores mean better outcome)	6 months
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of mortality	Mortality rate	1 month
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of mortality	Mortality rate	3 months
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of mortality	Mortality rate	6 months
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life	Score of the Short-Form 36 health Survey (from 0 to 100, highers scores mean better outcome)	1 month
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life	Score of the Short-Form 36 health Survey (from 0 to 100, highers scores mean better outcome)	3 months
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life	Score of the Short-Form 36 health Survey (from 0 to 100, highers scores mean better outcome)	6 months
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life	EuroQol 5 Dimensions 5 Levels surveys (from 0 to 1, highers scores mean better outcome)	1 month
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life	EuroQol 5 Dimensions 5 Levels surveys (from 0 to 1, highers scores mean better outcome)	3 months
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life	EuroQol 5 Dimensions 5 Levels surveys (from 0 to 1, highers scores mean better outcome)	6 months
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life	Proportion of patients returning to a professional activity	1 month
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life	Proportion of patients returning to a professional activity	3 months
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life	Proportion of patients returning to a professional activity	6 months
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression	Hospital and Anxiety Depression Scale (from 0 to 42, highers scores mean worse outcome)	1 month
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression	Hospital and Anxiety Depression Scale (from 0 to 42, highers scores mean worse outcome	3 months
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression	Hospital and Anxiety Depression Scale (from 0 to 42, highers scores mean worse outcome	6 months
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression	Pichot asthenia scale (from 0 to 32, highers mean worse outcome)	1 month
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression	Pichot asthenia scale (from 0 to 32, highers mean worse outcome)	3 months
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression	Pichot asthenia scale (from 0 to 32, highers mean worse outcome)	6 months
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption	Number of consultations with the healthcare professionals	1 month
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption	Number of consultations with the healthcare professionals	3 months
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption	Number of consultations with the healthcare professionals	6 months
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption	Rehospitalisation rate (all causes)	1 month
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption	Rehospitalisation rate (all causes)	3 months
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption	Rehospitalisation rate (all causes)	6 months
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Medico-economic evaluation	Incremental cost-effectiveness ratio	3 months
Secondary	Impact of a multidisciplinary and personalized rehabilitation program in terms of Medico-economic evaluation	Incremental cost-effectiveness ratio	6 months
Secondary	Patient's opinion concerning the rehabilitation program	Satisfaction questionnaire with open-ended questions (no specific scale is available)	3 months
Secondary	Patient's opinion concerning the rehabilitation program	Satisfaction questionnaire with open-ended questions (no specific scale is available)	6 months